scholarly journals Atrial fibrillation in unexplained syncope: observations from the Reveal LINQ registry

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Del Greco ◽  
A Natale ◽  
K Kusano ◽  
A Verma ◽  
S Beinart ◽  
...  

Abstract Background Implantable loop recorders (ILRs) have come to play an important role in the workup of patients with recurrent syncope of uncertain origin. In addition to detecting bradyarrhythmias related to syncope, which is the main diagnostic focus in these patients, ILRs are also capable of uncovering subclinical atrial fibrillation (AF). Purpose We sought to determine the percentage of patients monitored with an ILR for unexplained syncope who have AF detected and to describe clinical actions taken in these patients. Methods Patients enrolled in the Reveal LINQ Registry who received an ILR for unexplained syncope and had at least one follow-up form were included. The device automatically detects AF episodes lasting ≥2 minutes. Patients were considered to have AF based on an AF diagnosis made by the treating physician during follow-up or if device-detected AF was adjudicated as true AF by an external reviewer. AF detection rates were calculated using Kaplan-Meier methods. Results In total, 498 patients (aged 61.8±20.0 years, 49.6% female, CHA2DS2VASc score 2.2±1.7) were included and followed for 22±12 months. A history of AF was present in 97 (20%) patients, while 401 patients had no history. By 18 months, the incidence of AF was 70.9% (95% CI, 60.8%, 80.3%) in patients with a history of AF and 21.4% (95% CI, 17.4%, 26.1%) in patients without (Figure). AF detection in those with (30.4%) and without (30.1%) syncope during follow-up was similar. By the end of follow-up, and among patients with newly detected AF, 29/86 (33.7%) were on oral anticoagulation, 7 (8.1%) underwent AF ablation, 6 (7.0%) underwent other type of ablation, and 2 (2.3%) received cardioversion. Other actions among the whole cohort included implant of an IPG, ICD, or CRT in 98/498 (19.7%). Conclusion Among patients monitored with ILRs to determine the cause of recurrent syncope episodes, approximately 1 in 5 patients had new AF detected. In addition to improving the management of patients with syncope, ILR data served to support AF-related clinical decisions. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic Inc Incidence of AF according to baseline AF

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Proietti ◽  
M Vitolo ◽  
S Harrison ◽  
G.A Dan ◽  
A.P Maggioni ◽  
...  

Abstract Introduction Frailty is a major health determinant for cardiovascular disease. Thus far, data on frailty in patients with atrial fibrillation (AF) are limited. Aims To evaluate frailty in a large contemporary cohort of European AF patients, the relationship with oral anticoagulant (OAC) prescription and with risk of all-cause death. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. A 38-items frailty index (FI) was derived from baseline characteristics according to the accumulation of deficits model proposed by Rockwood and Mitnitsky. All-cause mortality was the primary study outcome. Results Out of the 11096 AF enrolled patients, data for evaluating frailty were available for 6557 (59.1%) patients who have been included in this analysis (mean [SD] age 68.9 [11.5], 37.7% females). Baseline median [IQR] CHA2DS2-VASc and HAS-BLED were 3 [2–4] and 1 [1–2], respectively. At baseline, median [IQR] FI was 0.16 (0.12–0.23), with 1276 (19.5%) patients considered “not-frail” (FI<0.10), 4033 (61.5%) considered “pre-frail” (FI 0.10–0.25) and 1248 (19.0%) considered “frail” (FI≥0.25). Age, female prevalence, CHA2DS2-VASc and HAS-BLED progressively increased across the FI classes (all p<0.001). Use of OAC progressively increased among FI classes; after adjustments FI was not associated with OAC prescription (odds ratio [OR]: 1.09, 95% confidence interval [CI]: 0.98–1.19 for each 0.10 FI increase). Conversely, FI was directly associated with vitamin K antagonist (VKA) use (OR: 1.26, 95% CI: 1.18–1.34 for each 0.10 FI increase) and inversely associated with non-VKA OACs (NOACs) use (OR: 0.82, 95% CI: 0.77–0.88). FI was significantly correlated with CHA2DS2-VASc (Rho= 0.516, p<0.001). Over a median [IQR] follow-up of 731 [704–749] days, there were 569 (8.7%) all-cause death events. Kaplan-Meier curves [Figure] showed an increasing cumulative risk for all-cause death according to FI categories. A Cox multivariable analysis, adjusted for age, sex, type of AF and use of OAC, found that increasing FI as a continuous variable was associated with an increased risk of all-cause death (hazard ratio [HR]: 1.56, 95% CI: 1.40–1.73 for each 0.10 FI increase). An association with all-cause death risk was found across the FI categories (HR: 1.71, 95% CI: 1.23–2.38 and HR: 2.88, 95% CI: 2.02–4.12, respectively for pre-frail and frail patients compared to non-frail ones). FI was also predictive of all-cause death (c-index: 0.660, 95% CI: 0.637–0.682; p<0.001). Conclusions In a European contemporary cohort of AF patients the burden of frailty is significant, with almost 1 out of 5 patients found to be “frail”. Frailty influenced significantly the choice of OAC therapy and was associated with (and predictive of) all-cause death at follow-up. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP programme, several companies have supported it with unrestricted grants.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Mahfoud ◽  
G Mancia ◽  
C Ukena ◽  
R Schmieder ◽  
K Narkiewicz ◽  
...  

Abstract Background/Introduction The win ratio is a new methodology which utilizes multiple hierarchical endpoints to evaluate clinical outcomes in trials. The win ratio may have added benefit in device therapy trials like renal denervation (RDN) where anti-hypertensive medication burden can influence blood pressure (BP) changes. Purpose In this analysis, we applied the win ratio to patients in the Global SYMPLICITY Registry (GSR) to quantify potential differences in RDN efficacy according to different comorbidities, specifically atrial fibrillation and obstructive sleep apnea. Methods All patients in GSR had an RDN procedure with the Symplicity Flex or Symplicity Spyral catheter. For the win ratio analysis, ambulatory systolic BP (ASBP) measurements, office systolic BP (OSBP) measurements and the number of prescribed anti-hypertensive medications at 6 months were included as hierarchical endpoints. Patients were divided into 1 of 2 groups: with or without atrial fibrillation (AF) at baseline. Each patient was compared with every other patient in the opposing group first according to ASBP to determine “win”, “lose” or “tie” with a threshold of 5 mmHg. Then, ties from the ASBP comparison underwent the comparison using OSBP with a threshold of 10 mmHg. Any tie for a pair comparing OSBP resulted in comparison of number of anti-hypertensive medications with a threshold of 1. Comparisons of ASBP and OSBP were adjusted for baseline SBPs by using residuals from a linear regression. The analysis was repeated for patients grouped according to history of obstructive sleep apnea (OSA) at baseline. Results In March 2020, 336 patients with AF at baseline and 2,394 patients with no AF were compared in GSR, resulting in 336 x 2394 = 804,384 pairwise comparisons for the win ratio analysis. A total of 285,709 “wins”, indicating greater ASBP reduction, OSBP reduction, and/or fewer number of anti-hypertensive medications occurred in the AF group compared to the no AF group. Conversely, 256,511 “losses”, meaning greater BP reduction and/or number of medications occurred in the no AF group. The win ratio was thus calculated as 1.11 (95% CI: 0.98, 1.28, p=0.081) indicating similar BP reduction and medication burden after RDN in patients with or without AF in GSR (Figure). Using these methods, the win ratio for patients with and without OSA was calculated to be 0.98 (95% CI: 0.85, 1.13, p=0.81), also indicating similar RDN efficacy regardless of presence of OSA at baseline (Figure). Previously published results of the win ratio analysis of RDN and sham control patients in the SPRYAL HTN-ON MED trial reported a win ratio in favor of RDN of 2.78 (95% CI: 1.58, 5.48, p<0.001). Conclusions Application of the win ratio methodology to patients in GSR demonstrated similar efficacy of RDN to patients regardless of whether they had comorbidities of atrial fibrillation or obstructive sleep apnea. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Vitolo ◽  
M Proietti ◽  
S Harrison ◽  
Z Kalarus ◽  
L Tavazzi ◽  
...  

Abstract Background Physical activity (PA) may have a beneficial contribution for outcomes in patients with atrial fibrillation (AF). Purpose We aimed to evaluate the impact of self-reported PA in a large contemporary cohort of European AF patients on the risk of all-cause mortality. Methods We analyzed patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. Self-reported PA was categorized, on the basis of reported time spent exercising, as follows: i) No PA; ii) Occasional PA; iii) Regular PA; iv) Intense PA. The primary outcome was all-cause death. Results Over 11096, a total of 8699 (78.4%) patients (mean age (SD) 69.1 (11.5); 40.7% female) had available data about PA and follow-up observation and were included in the analysis. Of these, 3703 (42.6%) reported no PA, 2829 (32.5%) occasional PA, 1824 (21.0%) regular PA, with only 343 (3.9%) reporting intense PA. With the 4 increasing PA categories, mean age, proportion of female patients, CHA2DS2-VASc and HAS-BLED scores were progressively lower (all p<0.001). Use of vitamin K antagonist (VKA) declined across the classes of PA (53.1% vs. 52.2% vs. 44.5% vs. 33.9%, p<0.001), while use of non-VKA OACs (NOACs) conversely increased. During a mean (SD) 680.6 (171.5) days of follow-up, there were a total of 848 (9.7%) all-cause death events. Based on Kaplan-Meier analysis, there was a progressively lower cumulative risk for all-cause death according to PA categories [Figure]. A multivariable Cox regression analysis, adjusting for CHA2DS2-VASc score, use of OAC at baseline and type of AF, found a lower risk of all-cause death associated with increasing levels of PA (Hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.59–0.81 for occasional PA, HR: 0.45, 95% CI: 0.35–0.58 for regular PA, HR: 0.41, 95% CI: 0.23–0.76 for intense PA, when compared to no PA). In a sensitivity analysis, a regular-intense PA was inversely associated with occurrence of cardiovascular (CV) death, after multivariable adjustments for comorbidities (HR: 0.54, 95% CI: 0.37–0.77). Conclusions In a large contemporary cohort of European AF patients, self-reported PA was found to be inversely associated with all-cause death and CV death. Kaplan-Meier Curves Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Since the start of EORP, several companies have supported the programme with unrestricted grants


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
F Goss ◽  
K Rybak ◽  
M Seige ◽  
W Haerer ◽  
B Schuetz ◽  
...  

Abstract Introduction The risk of neurovascular and cardiovascular morbidity is substantially increased by undetected atrial fibrillation (AF). Therefore, early detection of AF is crucial to initiate appropriate therapy in persons at risk and may improve outcome. An implantable loop recorder (ILR) can monitor the heart rhythm for up to three years, modern devices provide dedicated algorithms to detect AF. Hypothesis We aimed to investigate the AF detection rate by the use of an ILR in patients after a recent cerebrovascular event (TIA n=137 or stroke n=363) presenting in sinus rhythm and no history of AF in the ambulatory setting by office based cardiologists. Purpose Observational study in patients with no prior diagnosis of AF, who had (presumably thromboembolic) transient ischemic attack (TIA) or stroke within 12 months and were implanted an ILR in the last 6 months. Follow-up visits every 3 months for 1 year overall. Results In 34 outpatient cardiology centers in Germany, a total of 500 patients were documented (mean age 63.1±12.7 years, 35.4% >70 years; 60.8% males). The qualifying event - diagnosed by neurologists - was a TIA in 137 (27.4%) and a stroke in 363 (72.6%) with typical thromboembolic pattern in NMR imaging (29.2% TIA/45.2% stroke, p<0.001), in CT imaging (7.3% TIA/7.7% stroke, n.s.), in both (6.6% TIA/19.6% stroke, p<0.001). During follow-up, AF was newly detected by the device in TIA patients in 29.9% and in stroke patients in 25.6% (n.s.). The mean screening period until detection of AF with the Reveal LinQ device was 170±134 days in TIA, 145±128 in stroke respectively (n.s.). 95.7% had paroxysmal and 4.3% persistent AF in stroke, TIA patients had 100% paroxysmal AF (n.s.), median duration was 5.0 min in TIA and 5.2 min in stroke, respectively (n.s.). Most AF patients were asymptomatic (68.3% TIA/ 83.9% stroke, p<0.03). The mean CHA2DS2Vasc score in patients with AF was 4.0 and 4.1 in those with TIA and stroke (n.s.), for patients in sinus rhythm 3.7 and 3.9, respectively (n.s.). Arterial hypertension was present in 71.5% with TIA/76.0% with stroke (n.s.), diabetes mellitus in 15.3% with TIA/25.1% with stroke (p<0.05), coronary artery disease in 12.4% with TIA/14.6% with stroke (n.s.), vascular disease in 3.6% with TIA/5.0% with stroke (n.s.). Conclusions In patients in sinus rhythm and no history of AF after a TIA or stroke, during 1-year follow-up AF could be newly detected in a quarter of patients by means of systematic continuous screening with an implantable ECG device. As AF diagnosis usually leads to immediate secondary prevention with long-term anticoagulation, such screening is useful not only in stroke but also in TIA patients and may substantially reduce the risk of recurrent stroke and cardiovascular morbidity. Acknowledgement/Funding SPIDER-AF registry was performed by BNK Service GmbH, Munich (Germany) and supported by Bayer Vital GmbH and Medtronic GmbH in equal parts


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
I Doundoulakis ◽  
KA Gatzoulis ◽  
P Arsenos ◽  
P Dilaveris ◽  
D Tsiachris ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction: Syncope, whose cause is unknown after an initial assessment, has an uncertain prognosis. It is critical to identify patients at highest risk who may require a pacemaker and to identify the cause of recurrent syncope to prescribe proper therapy Purpose Aim of this study was to evaluate the effect of permanent pacing on the incidence of syncope in patients with unexplained syncope and electrophysiology study-proven atrioventricular node disease. Methods This was an observational study based on a prospective registry of 236 consecutive patients (60.20 ± 18.66 years, 63.1% male, 60.04 ± 9.50 bpm) presenting with recurrent unexplained syncope attacks admitted to our hospital for invasive electrophysiology study (EPS). Τhe implantation of a permanent antibradycardia pacemaker (ABP) was offered to all patients according to the results of the EPS. 135 patients received the ABP, while 101 denied. Results The mean of reported syncope episodes was 1.97 ± 1.10 (or presyncope 2.17 ± 1.50) before they were referred for a combined EP guided diagnostic and therapeutic approach. Over a mean follow-up of approximately 4 years (49.19 ±  29.58 months), the primary outcome event (syncope) occurred in 31 of 236 patients (13.1%), 6 of 135 (4.4%) in the ABP group as compared to 25 of 101 (24.8%) in the no pacemaker group (p &lt; 0.001). Conclusion Among patients with a history of unexplained syncope, a set of positivity criteria for the presence of EPS defined atrioventricular node disease, identifies a subset of patients who will benefit from permanent pacing.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Natale ◽  
SE Kasner ◽  
HC Diener ◽  
A Verma ◽  
A Amin ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic OnBehalf Reveal LINQ Registry Investigators Background Monitoring atrial fibrillation (AF) with an insertable cardiac monitor (ICM) provides objective data for clinicians to make decisions on oral anticoagulation (OAC) management, based on individual risk profiles. Whether ICM data is being used for that purpose has not been widely explored. Purpose To show the impact of AF burden measured by an ICM on OAC treatment initiation and discontinuation in patients with known AF. Methods Patients from the prospective, ongoing, multi-center Reveal LINQ Registry monitored for AF management, or pre- or post-ablation monitoring were eligible. Follow-up was scheduled every 6 months for up to 3 years. Patients were excluded if they had no AF data available within the last 6 months of follow-up (FU), or less than 6 months of FU and no change to their OAC treatment compared to baseline. AF burden was defined as the percentage of time in AF 6 months prior to last FU, excluding the first 3 months post-ablation for patients who had an ablation. Results The analysis included 225 patients (65 ± 10 years, 72% male, mean CHA2DS2-VASc score 2.1 ± 1.4) monitored with an ICM for 21.8 ± 7.9 months. At baseline, 164 (73%) were taking OAC therapy, 147 (65%) had a history of paroxysmal AF and 79 (35%) had persistent AF. Forty percent of patients had a history of atrial ablation prior to ICM insertion and 37% had ≥1 AF ablation procedure after ICM. Patients were grouped according to OAC status at baseline, CHA2DS2-VASc score and AF burden (Figure: bars show percentage of patients with a change in OAC status during monitoring). Patients at high risk of stroke and AF burden &gt;0.5% were more likely to initiate OAC therapy, whereas patients with higher AF burden were less likely to discontinue OAC, regardless of their risk score. Among those with no AF burden detected during the last 6 months of follow-up and on OAC at baseline, approximately half discontinued OAC, whereas 1/3 of patients with high risk score had initiated OAC, despite having no AF detected. Conclusion Our results derived from real-world practice show that AF detected and quantified by an ICM influences OAC therapy management in patients with known AF. Many patients with a low CHA2DS2-VASc score and no AF or low AF burden have had OAC therapy discontinuation, whereas a high proportion of patients with high AF burden have initiated OAC, regardless of their risk score. Abstract Figure. OAC according to risk and AF burden


Author(s):  
Shinwan Kany ◽  
Johannes Brachmann ◽  
Thorsten Lewalter ◽  
Ibrahim Akin ◽  
Horst Sievert ◽  
...  

Abstract Background Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death. Methods Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE). Results A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02–2.72, p = 0.041). Conclusion Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality. Graphic abstract


2015 ◽  
Vol 113 (01) ◽  
pp. 185-192 ◽  
Author(s):  
Chun-Cheng Wang ◽  
Cheng-Li Lin ◽  
Guei-Jane Wang ◽  
Chiz-Tzung Chang ◽  
Fung-Chang Sung ◽  
...  

SummaryWhether atrial fibrillation (AF) is associated with an increased risk of venous thromboembolism (VTE) remains controversial. From Longitudinal Health Insurance Database 2000 (LHID2000), we identified 11,458 patients newly diagnosed with AF. The comparison group comprised 45,637 patients without AF. Both cohorts were followed up to measure the incidence of deep-vein thrombosis (DVT) and pulmonary embolism (PE). Univariable and multivariable competing-risks regression model and Kaplan-Meier analyses with the use of Aelon-Johansen estimator were used to measure the differences of cumulative incidences of DVT and PE, respectively. The overall incidence rates (per 1,000 person-years) of DVT and PE between the AF group and non-AF groups were 2.69 vs 1.12 (crude hazard ratio [HR] = 1.92; 95 % confidence interval [CI] = 1.54-2.39), 1.55 vs 0.46 (crude HR = 2.68; 95 % CI = 1.97-3.64), respectively. The baseline demographics indicated that the members of the AF group demonstrated a significantly older age and higher proportions of comorbidities than non-AF group. After adjusting for age, sex, and comorbidities, the risks of DVT and PE remained significantly elevated in the AF group compared with the non-AF group (adjusted HR = 1.74; 95 %CI = 1.36-2.24, adjusted HR = 2.18; 95 %CI = 1.51-3.15, respectively). The Kaplan-Meier curve with the use of Aelon-Johansen estimator indicated that the cumulative incidences of DVT and PE were both more significantly elevated in the AF group than in the non-AF group after a long-term follow-up period (p<0.01). In conclusion, the presence of AF is associated with increased risk of VTE after a long-term follow-up period.


2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Karapet Davtyan ◽  
Victoria Shatakhtsyan ◽  
Hermine Poghosyan ◽  
Alexandr Deev ◽  
Alexey Tarasov ◽  
...  

Introduction. While several studies have compared the radiofrequency current (RFC) and cryoablation for the treatment of patients with atrial fibrillation (AF), no study has monitored the long-term outcomes with the usage of implantable loop recorders (ILRs). Methods. We enrolled 89 consecutive patients with nonvalvular paroxysmal AF (N=44 for RFC and N=45 for cryoballoon). The primary efficacy end point was the assessment of effectiveness for each group (RFC versus cryoballoon) when examining freedom from arrhythmia by monitoring with ECG, Holter, and implantable loop recoder (ILR). The primary safety end point compared rates of adverse events between both groups. The secondary efficacy end point examined the duration of the postablation blanking period from ILR retrieved data. Results. The mean age of the study population was 56.6±10.2 years, and the follow-up duration was 12 months. There were no differences in baseline patient characteristics between groups. At 12 months, the absolute effectiveness (measured by ILR) was 65.9% in the RFC group and 51.1% in the cryoballoon group (OR = 1.85; 95% CI: 0.79–4.35; p=0.157), and the clinical effectiveness (measured by ECG and Holter) was 81.8% in the RFC group and 55.6% in the cryoballoon group (OR = 3.6; 95% CI: 1.37–9.46; p=0.008). There was no difference in safety between both groups. Asymptomatic episodes were significantly more present in the RFC group as measured by ILRs (p<0.010). In cryoballoon group, arrhythmia episodes were recorded equally irrespective of the follow-up method (i.e., ECG and Holter versus ILR (p>0.010)). The blanking period does not seem to be as important in cryoballoon as compared to RFC. Conclusion. RFC and cryoballoon ablation had similar absolute effectiveness at 12 months. ECG and Holter were effective when assessing the efficacy of the cryoballoon ablation; however, in the RFC group, ILR was necessary to accurately assess long-term efficacy.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
P Loh ◽  
MHA Groen ◽  
K Taha ◽  
FHM Wittkampf ◽  
PA Doevendans ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Abbott Background Irreversible electroporation (IRE) is a promising new non-thermal ablation technology for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). First in human studies demonstrated the feasibility and safety of IRE PVI. Objective Further investigate the safety of IRE PVI. Methods Twenty patients with symptomatic AF underwent IRE PVI under conscious sedation. Oral anticoagulation was uninterrupted and heparin was administered to maintain activated clotting time at 300-350 seconds. Non-arcing, non-barotraumatic 6 ms, 200 J IRE applications were delivered via a custom non-steerable 8 F, 14-polar circular IRE ablation catheter with a variable hoop diameter (16-27 mm). Voltage mapping  of the left atrium and the PVs was performed before and after ablation with a conventional circular mapping catheter. For both catheters a single transseptal access (8 F introducer, Agilis NxTTM) was used. Adenosine testing was performed after a 30-minute waiting period. On day 1 after ablation, patients underwent esophagoscopy and brain MRI (DWI/FLAIR). If abnormalities were detected, examinations were repeated in due time. Results In 20 patients, all 80 PVs could be successfully isolated with a mean of 11,8 ± 1,4 IRE applications per patient. Average time from first to last IRE application was 22 ± 5 minutes, total procedure duration was 107 ± 13 minutes and total fluoroscopy time was 23 ± 5 minutes. One PV reconnection occurred during adenosine testing, re-isolation was achieved with 2 additional IRE pulses. No periprocedural complications were observed. Brain MRI on day 1 after ablation showed punctate asymptomatic lesions in 3/20 patients (15%). At follow-up MRI the lesion disappeared in 1 patient while in the other 2 patients 1 lesion persisted. Esophagoscopy on day 1 showed an asymptomatic esophageal lesion in 1/20 patients (5%), at repeat esophagoscopy on day 22 the lesion had resolved completely. Conclusion Acute electrical PV isolation could be achieved safely and rapidly by IRE ablation under conscious sedation in 20 patients with symptomatic AF. Acute silent cerebral lesions were detected in 3/20 patients (15%) and may be due to ablation or to changes of therapeutic and diagnostic catheters over a single transseptal access.


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